The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Direct Sl Outer Catheter.
Device ID | K053277 |
510k Number | K053277 |
Device Name: | CPS DIRECT SL OUTER CATHETER |
Classification | Catheter, Percutaneous |
Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
Contact | Deanna Hughes |
Correspondent | Deanna Hughes ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-23 |
Decision Date | 2006-02-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05414734508858 | K053277 | 000 |
05414734504287 | K053277 | 000 |